1??NAME OF THE MEDICINAL PRODUCT
Etamsylate Solution for Injection 250mg/2ml
2??QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient is etamsylate 125mg/ml of injection solution. (250mg per 2 ml ampoule).
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection (injection).
A clear, colourless, aqueous solution for injection (pH 6.2 to 6.8).
4??CLINICAL PARTICULARS
- Therapeutic Indications
Etamsylate for Injection is indicated in neonates.
Etamsylate for Injection is used clinically for the prophylaxis and treatment of periventricular haemorrhage (bleeding into the brain immediately adjacent to cerebral ventricles) in low birth weight infants (< 1.5 Kg).
4.2??Posology and method of administration
Neonates only:
The normal dosage is 12.5mg/kg body weight given by intravenous or intramuscular route within an hour of birth and every six hours for the first 4 days of life.
Clinical studies have not been performed in patients presenting hepatic or renal impairment. Consequently, caution is required when administering Etamsylate for Injection to these patients.
4.3??contraindications
Use in patients with a known hypersensitivity to etamsylate or to any of the excipients. Acute porphyria
Bronchial asthma confirmed hypersensitivity to sulphites.
4.4??Special warnings and precautions for use
Etamsylate for Injection is intended for neonatal use only.
If the infant develops a fever then treatment should be discontinued.
Due to the risk of a fall in blood pressure during parenteral administration, caution is required in patients presenting unstable pressure or hypotension (see section 4.8 ?undesirable effects?).
Etamsylate for Injection solution contains sodium metabisulphite as an antioxidant, which may cause allergic reactions, nausea and diarrhoea in susceptible patients.
The allergic reactions may go as far as anaphylactic shock and cause life-threatening
asthma attacks. The prevalence in the population is not known but is probably low. However, hypersensitivity to sulphites is observed more frequently in patient with asthma than in those without asthma (see section 4.3 “Contraindications”). If a hypersensitivity reaction occurs, the administration of Etamsylate for Injection solution must be stopped immediately.
4.5??Interaction with other medicinal products and other forms of interaction
Etamsylate for Injection is incompatible with solutions of sodium bicarbonate and compound sodium lactate. When Etamsylate for Injection is mixed with saline it should be used immediately.
Thiamine (vitamin B1) is inactivated by the sulphite contained in Etamsylate for Injection. If a dextran infusion is required, Etamsylatemust is injected first.
4.6??Fertility, pregnancy and lactation
Clinical use is not relevant for this indication.
There are no clinical data available concerning use in pregnant women.
Animal experiments have not revealed any direct or indirect toxicity affecting pregnancy, embryonic development, foetal development and/or post-natal development.
Caution is required if used during pregnancy.
In the absence of data concerning passage into breast milk, breast-feeding is inadvisable during treatment. Alternatively, the treatment should be stopped if breast-feeding is continued.
4.7??Effects on ability to drive and use machines
Not applicable in this population.
In adults, DICYNENE injection has no effect upon driving capacity and managing of machines.
4.8??Undesirable effects
In infants, no major side-effects have been reported.
In adults, the following side effects were described. These side effects are classified according to the MedDRA convention by system organ class and by frequency as follows:
Very common (?1/10) Common (?1/100 to <1/10)
Uncommon (?1/1 000 to <1/100) Rare (?1/10 000 to <1/1 000) Very rare (<1/10 000), not known (cannot be estimated from the available data)
Gastrointestinal disorders
Common: nausea, diarrhoea, abdominal discomfort.
Skin and subcutaneous tissue disorders
Common: rash.
General disorders and administration site conditions
Common: asthenia Very rare: fever.
Nervous system disorders
Common: headache.
Vascular disorders
Very rare: thromboembolism, hypotension.
Blood and lymphatic system disorders
Very rare: agranulocytosis, neutropenia, thrombocytopenia
Musculoskeletal and connective tissue disorders
Rare: arthralgia
Immune system disorders
Very rare: hypersensitivity
These reactions are generally reversible when stopping treatment course.
In case of skin reactions or fever, the treatment must be stopped and the treating physician informed as this may constitute hypersensitivity reactions.
4.9??Overdose
There is no experience of overdosage with Dicynene.
In the event of an overdose, start symptomatic treatment.
5 PHARMACOLOGICAL PROPERTIES
- Pharmacodynamic properties
Other systemic haemostatics.
Etamsylateis a non-hormonal agent which reduces capillary exudation and blood loss. Etamsylatedoes do not affect the normal coagulation mechanism since the administration is without effect on prothrombin times, fibrinolysis, platelet count or function.
Etamsylateis thought to act by increasing capillary vascular wall resistance and platelet adhesiveness; in the presence of a vascular lesion, it inhibits the biosynthesis and action of those prostaglandins which cause platelet disaggregation, vasodilation and increased capillary permeability. Etamsylatedoes do not have a vasoconstricting action.
5.2??Pharmacokinetic properties
Following intravenous administration, maximum blood levels of etamsylate are achieved in 2-3 minutes, while after intramuscular injection, maximum blood levels of etamsylate are achieved after about one hour. Etamsylate is excreted unchanged, largely by the urinary route.
5.3??Preclinical safety data
No further information is available.
6 PHARMACEUTICAL PARTICULARS
- List of excipients
Sodium metabisulphite
Sodium hydrogen carbonate (for pH adjustment) Water for injections
6.2??Incompatibilities
Etamsylate for Injection is incompatible with solutions of sodium bicarbonate and compound sodium lactate.
6.3??Shelf life
Unopened: 3 years
Once opened: from a microbiological point of view the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 oC, unless dilution has taken place in controlled and validated aseptic conditions
6.4??Special precautions for storage
Store below 25?C. Keep the ampoule in the outer carton.
6.5??Nature and contents of a container
2 ml clear, Type I glass ampoules containing a colourless, sterile, aqueous solution. Outer cartons containing 10 X 2 ml ampoules.
6.6???Special precautions for the disposal of a used medicinal product or waste materials derived from such medicinal product and another handling of the product
Discard if the solution is coloured.
For single use only, any remaining solution should be discarded.
7. Manufactured in India by:
TAJ LIFE SCIENCES PVT. LTD.
Unit No. 214, Old Bake House,
Bake House Lane, Fort,
Mumbai-400001
at: Ahmedabad- Gujarat, INDIA.
Ho.NO. +91 8448 444 095
Toll Free Phone: (1800-222-434 / 1800-222-825)